Factors affecting the feasibility of post-authorisation RCTs for conditionally authorised anticancer medicines: a multistakeholder perspective from a qualitative focus group study
Based on the identified factors, our findings suggest that patient recruitment and retention could be assessed more in-depth during regulatory feasibility assessments at the time of granting conditional marketing authorisation and that sponsors and regulators should better inform patients and physicians about the remaining uncertainties for conditionally authorised medicines and the necessity for post-authorisation RCTs. By enhancing the evaluation of trial feasibility, timely completion of post-authorisation RCTs may be facilitated to resolve the remaining uncertainties within a reasonable timeframe.
Authors
- Jarno Hoekman (ORCID: https://orcid.org/0000-0002-2817-1229)
- Lourens T. Bloem (ORCID: https://orcid.org/0000-0002-0014-8625)
- Paula B. van Hennik (ORCID: https://orcid.org/0000-0002-6950-1458)
- Gabe S. Sonke (ORCID: https://orcid.org/0000-0001-8088-9628)
- Christine van Hattem (ORCID: https://orcid.org/0009-0001-3619-1721)
- K.E. Broekman (ORCID: https://orcid.org/0000-0003-4178-8714)
- Amos J. de Jong (ORCID: https://orcid.org/0000-0002-6860-9213)
- Jolien S. de Groot
Institutions
- University Medical Center Groningen (NL)
- Utrecht University (NL)
- The Netherlands Cancer Institute (NL)
- Medicines Evaluation Board (NL)
- University of Amsterdam (NL)
Publication Details
- Journal
- BMJ Open
- Published
- 2024-11-01
- DOI
- https://doi.org/10.1136/bmjopen-2024-084483
- Citations
- 3
- Primary Topic
- Economic and Financial Impacts of Cancer
- Type
- article
- Field-Weighted Citation Impact
- 3.39
Funders
- Universiteit Utrecht
- College ter Beoordeling van Geneesmiddelen
- KWF Kankerbestrijding
- Radboud Universitair Medisch Centrum